(96 days)
No
The document describes a mechanical implant (humeral cups) and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is an implantable prosthesis (Total Shoulder System) used to replace a diseased or damaged joint, which directly treats a medical condition.
No
This device is a prosthetic shoulder implant, not a diagnostic tool. Its intended use is to replace a diseased or damaged shoulder joint.
No
The device description explicitly states the device is made of polyethylene and is a line extension to humeral cup system components, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant intended for use in the shoulder joint to replace damaged parts. It is a physical device implanted within the body, not a device used to test samples outside the body.
The information provided is consistent with a submission for a Class II or Class III medical device (specifically, a prosthetic implant) that requires regulatory clearance for surgical use.
N/A
Intended Use / Indications for Use
The Delta CTA™ Humeral Cups, as part of the DePuy Delta CTA™ Total Shoulder are intended for use in patients with non-functional rotator cuffs with or without bone cement.
The Delta CTA™ Total Shoulder Prosthesis is indicated for use in grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
Product codes
KWS
Device Description
The Delta CTA™ Humeral Cups proposed in this submission are a line extension to the humeral cup system components cleared in the DePuy Delta CTA™ Shoulder submission (cleared as DePuy Delta Shoulder under K021478, November 18, 2003). The additional humeral cups are made of polyethylene and will be available in four sizes: 36mm diameter + 3mm thickness, 36mm diameter + 9mm thickness, 42mm diameter + 3mm thickness and 42mm diameter + 9mm thickness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
MAY 1 6 2005
lqz
510(k) Summary
NAME OF SPONSOR:
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Est. Reg. No. 1818910
MANUFACTURER:
DePuy France S.A. ZILa Vendue BP88 Chaumont 52003 France Est. Reg. No. 9615674
510(K) CONTACT:
Natalie S. Heck Manager, Regulatory Affairs Phone: (574) 372-7469 FAX: (574) 371-4987
Delta CTA™ Humeral Cups
TRADE NAME:
COMMON NAME:
CLASSIFICATION:
Shoulder Prosthesis
Class II Device per 21 CFR 888.3660: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
DEVICE PRODUCT CODE:
87 KWS
SUBSTANTIALLY EQUIVALENT DEVICES:
DePuy Delta Shoulder, K021478
DEVICE DESCRIPTION:
The Delta CTA™ Humeral Cups proposed in this submission are a line extension to the humeral cup system components cleared in the DePuy Delta CTA™ Shoulder submission (cleared as DePuy Delta Shoulder under K021478, November 18, 2003). The additional humeral cups are made of polyethylene and will be available in four sizes: 36mm diameter + 3mm thickness, 36mm diameter + 9mm thickness, 42mm diameter + 3mm thickness and 42mm diameter + 9mm thickness.
1
510(k) Summary (cont.)
INTENDED USE AND INDICATIONS:
The Delta CTA™ Humeral Cups, as part of the DePuy Delta CTA™ Total Shoulder are intended for use in patients with non-functional rotator cuffs with or without bone cement.
The Delta CTA™ Total Shoulder Prosthesis is indicated for use in grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
BASIS OF SUBSTANTIAL EQUIVALENCE:
DePuy believes the humeral cups proposed in this submission are substantially equivalent to the humeral cups cleared in the previous DePuy Delta CTA™ Total Shoulder Prosthesis submission. The design, material and manufacturing method of the humeral cups is identical to those cleared in K021478 (cleared November 18, 2003), however the range of sizes of available cups will be increased to 36mm diameter + 3mm thickness, 36mm diameter + 9mm thickness, 42mm diameter + 3mm thickness and 42mm diameter + 9mm thickness. Currently, humeral cups compatible with the Delta CTA™ Total Shoulder prosthesis are available in 36mm diameters in +0mm and + 6mm thicknesses, and 42mm diameters in +0mm and + 6mm thicknesses.
2.12
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2005
Ms. Tiffani D. Rogers DePuy Orthopaedics Incorporated P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K050315
Trade/Device Name: Delta CTA™ Humeral Cups Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: April 15, 2005 Received: April 20, 2005
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for asc stated in the encreate) to 10gains the Medical Device Amendments, or to commerce provision to May 20, 1978, in ecordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic 7.0. (71ct) that to nevies, subject to the general controls provisions of the Act. The 1 ou may, therefore, maines of the Act include requirements for annual registration, listing of general Controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is elassified (660 ace v) in 1. Existing major regulations affecting your device It inay be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Ood or ements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean F Icase oc advised that I Dri 3 issualles of our device complies with other requirements of the Act that IDA has made a actorinments in administered by other Federal agencies. You must of any I cuchares and regaranents, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, n.e., and 801); good manufacturing practice requirements as set Crith in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 fordin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Tiffani D. Rogers
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manieting of substantial equivalence of your device to a legally premarket notification: "The PDT intacle sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice 10. J at (240) 276-0120 . Also, please note the regulation entitled, Comace the Office of Compilance in (21CFR Part 807.97). You may obtain Missuranting Uy Terefone to premainsmonibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stypt Rhode
Na. Virginia C.B., D.st, Ph.D.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Delta CTA™ Humeral Cups
Indications for Use:
A Delta Total shoulder prosthesis is indicated for use in:
Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is neoessary to use the device.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
X Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ﻴﺔ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟ
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K050315